MAUDE Adverse Event Report: RICHARD WOLF GMBH SHARK; INTERNAL SHEATH RESECTOSCOPE 22FR

Model Number	8675322
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Rw gmbh considers this mdr/complaint open.A follow up report will be submitted once additional information are available and the investigation has been completed.
Event or Problem Description
On september 28, 2020 richard wolf gmbh was informed by richard wolf france about an adverse event.On (b)(6) 2020, during the surgery, the ceramic tip of the internal rotating sheet ch24, "fell into the patient." the tip has separated from the stainless steel sheet.The tip neither twisted nor split.It has "taken off".The rotating jacket was put into service in november 2016.
Additional Manufacturer Narrative
The following sections include new or changed information: b4, g6, h2, h3, h6 and h10.During the inspection of the inner shaft, it was found that there is mechanical damage to the shaft.Among other things there is a dent proximally on the shaft tube.The ceramic insulation insert is broken off in one piece at the edge of the shaft tube.A longitudinal crack is visible on the fragment.The bonding of the ceramic insulating insert to the shaft tube is still intact.The user reported that it took about 15 minutes of additional work to recover the broken ceramic insulation insert.We consider this extension of the operating time to be acceptable and not significant.We assume a user error.In the ga-d366 instructions for use, the user is informed about the limited stability as well as the visual and functional checks before and after the application.In chapter 8.1.2 we explicitly deal with the ceramic insulation.Warning! danger of injury! incorrect handling, e.G.Fall, shock, blows or similar mechanical loads can cause hair cracks and / or spalling of the ceramic coating in the distal area of the resectoscope sheath.Injuries of the patient, user or third parties are possible.Mind surface changes and ensure safe handling.Do not use damaged resectoscope sheaths, return damaged sheaths for repair.Check the ceramic insulation at the distal end of the resectoscope sheath for damage before every use.Based on a review of the complaint database, no trends or systemic problems related to a product problem are indicated according to meddev 12-1 rev.8 vigilance 5.1.5.1, we consider this case as a non-notifiable user error as the user has been clearly informed in the instructions for use about the risks and dangers of the ceramic insulation.Richard wolf gmbh (rwgmbh) considers this matter closed.However if rwgmbh receives any additional information a follow up report will be submitted to fda.Richard wolf medical instruments corporation (rwmic is submitting this report on behalf of rwgmbh.

• Brand Name: SHARK
• Common Device Name: INTERNAL SHEATH RESECTOSCOPE 22FR
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 10758473
• Report Number: 9611102-2020-00023
• Device Sequence Number: 16990470
• Product Code: FJL
• UDI-Device Identifier: 04055207019641
• UDI-Public: 04055207019641
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K062720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8675322
• Device Catalogue Number: 8675322
• Device Lot Number: 1326669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Initial Date Received by Manufacturer: 09/28/2020
• Supplement Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1